Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assi
The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy wi
| Condition(s) | Prostate Cancer, Erectile Dysfunction |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure |
| Who can participate | Inclusion Criteria: 1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of: 1. Gleason grade ≥8 2. PSA ≥20 3. \>pT2 on preoperative MRI imaging 2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17 Exclusion Criteria: 1. Patients with previous pelvic surgery 2. Patients with previous pelvic radiotherapy 3. Patient with previous focal therapy for prostate cancer 4. Patients aged \< 18 years at diagnosis 5. Legally incapable patients 6. Patients who are unable to complete questionnaires and have no companion to help complete them 7. Patients undergoing a concomitant cancer surgery 8. Patients with pre-existing neurologic disease |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Sir Mortimer B. Davis - Jewish General Hospital |
| Locations | Montreal, Quebec, Canada; Montreal, Quebec, Canada |
| Start date | 2024-09 |
| NCT ID | NCT06521710 |
| Official listing | https://clinicaltrials.gov/study/NCT06521710 |